Effectiveness of Donor Human Milk Supplementation for the Treatment of Hypoglycemia in the Breastfed Infant

Neonatal Hypoglycemia Clinical Trial

Official title:

Effectiveness of Donor Human Milk Supplementation Compared to Infant Formula for the Treatment of Hypoglycemia in the Breastfed Infant in the Normal Newborn Nursery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04030312
• Other study ID #: 0119-19-EP
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: April 10, 2023

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare if newborn infant hypoglycemia can be improved with bottle supplementation of commercially-sterilized donor human milk compared to standard infant formula. Hypothesis is that supplementation with commercially-sterilized donor human milk will improve hypoglycemia and limit formula use in exclusively breastfed infants.

Description:

Enrolled infant participants will receive a maximum of two bottle feeding supplementations (of their designated treatment arm for either 20 calorie-per-ounce commercially-sterilized donor human milk OR 20-calorie-per-ounce standard infant formula) as treatment if they meet hypoglycemia criteria. Infant participants will complete the study if 1) they have received two bottle feeding supplementations for treatment of hypoglycemia, 2) they only received one bottle supplementation and hypoglycemia resolved, 3) if the medical teams deems the infants requires a higher level of care for their hypoglycemia (example: admission to the newborn intensive care unit for intravenous fluids with dextrose).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 10, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Minute to 72 Hours

Eligibility

Mother-infant pairs will be consented for participation via informed written consent.

Inclusion Criteria:

• Mother/infant dyads deliverying at Nebraska Medicine hospital (Omaha, NE, USA).
• Infant in the normal newborn nursery, born greater than or equal to 36 weeks gestational age.
• Infant with blood glucose after delivery of < 40 milligrams/deciliter within the first four hours of life OR blood glucose levels less than 45 milligrams/deciliter after four hours of life
• Deliverying mother plans to exclusively breastfeed.

Exclusion Criteria:

• Infants born and directly admitted to the newborn intensive care unit
• Infants with known congenital abnormality or known inborn error of metabolism that influences growth and metabolic outcomes
• Infants deemed ward of state
• Mothers who do not plan to exclusively breastfeed at time of delivery
• Mothers less than 19 years of age

Related Conditions & MeSH terms

• Hypoglycemia
• Neonatal Hypoglycemia

Intervention

Dietary Supplement:
• Bottle Supplementation--Commercially-Sterilized Donor Human Milk
Supplementation by bottle with 20-calorie-per-ounce commercially-sterilized donor human milk (up to 15 ml, up to two times) for infants meeting hypoglycemia criteria and randomized to this treatment arm.
• Bottle Supplementation--Standard Infant Formula
Supplementation by bottle with 20-calorie-per-ounce standard infant formula (up to 15 ml, up to two times) for infants meeting hypoglycemia criteria and randomized to this treatment arm.

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of Resolving Neonatal Hypoglycemia: Blood glucose levels	To compare the effectiveness of commercially-sterilized donor human milk bottle supplementation for the treatment of hypoglycemia in the breastfed infant in the normal newborn nursery compared to bottle supplementation with standard infant formula.	Blood glucose levels will be monitored within 60 minutes of initiating a feeding. Overall outcomes for each treatment arm will be compared at the completion of the study for all enrolled participants.
Secondary	Exclusive Breastfeeding Duration	To assess if donor human milk supplementation (when compared to formula supplementation) impacts rate of exclusive breastfeeding during the first 6 months of life.	Families of consented participants will be contacted when the enrolled infant is 6 months old.
Secondary	Parenteral Satisfaction of Infant Feeding: Parenteral satisfaction surveys	To compare if donor human milk supplementation (when compared to formula supplementation) improves parental satisfaction related to infant feeding during post-partum hospitalization.	Parenteral satisfaction surveys will be completed prior to mother's hospital discharge (within 72 hours following delivery).